What are the responsibilities and job description for the Document Controller position at The CREW Corporation?
This position serves a local pharmaceutical company in downtown Indianapolis, and it is as secure as most direct-hire positions. It is one of three positions that have supported this department for OVER 10 years.
It is NOT a short-term or multi-year contract position! As with almost all CREW’s positions, it is an executive-approved need for long-term, on-going support. As a point of reference, 72% of our employees have been with us for two or more years, and 40% of our employees have been with CREW five years or more. The position is as secure as most direct-hire positions, really!
In this position you will be routing documents using Quality Docs (an EDMS) through multiple edits and approvals to ensure the customer is meeting the FDA and EU regulatory requirements and is adhering to rigid timelines. In other words, you will proof, make minor edits, format, follow up, and follow through at every step in the process to ensure that documents are accurate and compliant. The work is almost exclusively performed using a computer with some group meetings.
Although very few CREW employees obtain an offer from our customers, it does happen. This CREW backfill position is open due to one of those rare instances.
Must-have Requirements:
Minimum of 3 years of proven experience:
· Using an EDMS (Electronic Document Management System) in a regulated environment. (Preferred experience in QualityDocs)
· Applying critical thinking.
· Demonstrating high agility, including multi-tasking, prioritizing, and working independently to achieve on-time or early results.
· Providing a high level of attention to detail in a fast-paced, changing environment, ensuring 100% accuracy (ensured by second person verifications) to meet all FDA and EU regulations. (Regulatory agencies audit the work; errors can be extremely costly.)
Additional Strong Preferences:
· Proficient in MS Office applications (Especially Word and Excel. Visio, OneNote and PowerPoint a plus).
· Ability to simplify complex information and communication the results to all levels of the organization.
· Demonstrated strong written and verbal communication.
· Professionalism – ability to interact with customers and colleagues at all levels of the organization.
· Good problem-solving skills: able to anticipate and recognize problems, diagnose the cause and take appropriate action to prevent recurrence.
Position Tasks:
- Format, edit and route quality system documents.
- Serve as QualityDocs document controller, managing the review/approval workflow of quality system documents.
- Evaluate content, fact check content’s logical intent/meaning and recommend content phrasing improvements.
- Communicate and work with customers to resolve formatting issues in Word.
- Communicate document statuses.
- Route periodic review workflows and revisions.
- Post and publish documents on effective dates.
- Edit and update content on SharePoint collaboration sites.